Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

Browse trials for

• Pneumonia 2,044
• Pneumonia, Pneumococcal 121

Keywords

• pneumococcal conjugate vaccine
• polysaccharide vaccine
• PPV
• PCV
• Streptococcus pneumoniae
• Prevnar
• Pneumovax
• HIV

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 275 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 84 studies on the registry; 18 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Group 1

  PCV, 210 patients

  Biological: pneumococcal conjugate vaccine

• Active comparator
  Group 2

  PPV, 110 patients

  Biological: pneumococcal polysaccharide vaccine

• Active comparator
  Group 3

  PCV, HIV-negative, 25 patients

  Biological: pneumococcal conjugate vaccine

Interventions

• Biologicalpneumococcal conjugate vaccine

  Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.

  Also known as: PCV

• Biologicalpneumococcal polysaccharide vaccine

  PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

  Also known as: PPV

Primary outcomes

1. Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms

   The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.

   Time frame: Day 14, 60, and 180 after vaccination

2. Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination

   Time frame: Day 7 after vaccination

Secondary outcomes

1. Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.

   The pairwise change in CD4+ cell count from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination) (CD4+ cell count at day 14/60/180 \[minus\] CD4+ cell count at screening). Analysis Population Description (further details): not all participants completed each follow-up visit. Therefore, a different number of participants analyzed is noted for each visit day. For example, in Group 1, 131 participants completed the screening visit but only 129 completed Day 14, and only 123 completed Day 60, etc.

   Time frame: Day 14, 60, and 180 after vaccination

2. Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.

   Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2)

   Time frame: Day 60 after vaccination

3. Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.

   The pairwise change in viral load from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination), similar to CD4 change above.

   Time frame: Day 14, 60, and 180 after vaccination

Baseline characteristics

1 further baseline measures are reported on the registry.

Publications

• Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Agan B, Medina S, Rahkola J, Hale B, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine. 2010 Nov 10;28(48):7583-8. doi: 10.1016/j.vaccine.2010.09.056. Epub 2010 Sep 29. PubMed 20887830 ↗
• Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147. PubMed 20795819 ↗